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OpenTrials
Completed

NCT Number: NCT00937430

Bowel Preparation and Pelvic Organ Prolapse Surgery

The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.

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Key information

Age range

21 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are between the ages of 21-90 years.
  • Have a posterior vaginal wall prolapse.
  • Are undergoing vaginal prolapse reconstructive surgery including posterior repair with suspension of the vaginal apex (top) to the ligaments in your pelvis, repair of the cul de sac or "enterocele", with or without anti-incontinence surgery.
  • Are receiving general anesthesia.

Exclusion criteria

  • Patient undergoing concomitant anal sphincteroplasty, rectovaginal fistula repair, rectopexy, or rectal resection/reanastomosis.
  • Patient undergoing any mesh augmentation.
  • Patient with any neurological condition involving bowel function.
  • Patient on regular narcotic medication preoperatively.
  • Patient does not want to be in the group she was randomized to.
  • Patient currently pregnant or planning to become pregnant, or breastfeeding.
  • Patient with ascites.
  • Patient with known or suspected gastrointestinal obstruction or perforation.
  • Patient with history of hyperparathyroidism.
  • Patient with dehydration.
  • Patient with active inflammatory bowel disease.
  • Patients with congestive heart failure.
  • Patients with dialysis dependent renal disease.

Treatment and study plan

Bowel preparation (Fleets enema)

Other

Use of Bowel preparation (Fleets enema)

Primary outcomes

  1. Measure the return of bowel function after pelvic organ prolapse surgery.

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.